By Meera Jagannathan
Against the grim backdrop of record-breaking COVID-19 hospitalizations and deaths , the two vaccine makers closest to gaining emergency-use authorization from the Food and Drug Administration — Pfizer /zigman2/quotes/202877789/composite PFE +1.78% with its German partner, BioNTech /zigman2/quotes/214419716/composite BNTX +6.68% , and Moderna /zigman2/quotes/205619834/composite MRNA +5.26% — have announced encouraging early efficacy results from late-stage clinical trials.
Pfizer and Moderna are both developing a messenger ribonucleic acid (mRNA) vaccine, a new kind of vaccine that teaches cells to create proteins that generate an immune response. The U.S. has not currently licensed any mRNA vaccines. Two other companies, Johnson & Johnson /zigman2/quotes/201724570/composite JNJ -1.06% and AstraZeneca /zigman2/quotes/200304487/composite AZN +0.89% in partnership with the University of Oxford, have vector-based vaccine candidates in late-stage trials.
Both Pfizer and Moderna say their candidates are around 95% effective based on early analyses, but have yet to publish detailed findings in peer-reviewed medical journals.
While it will likely be months before you, your family members and friends can get vaccinated, you probably have some questions. Here’s what we know so far, according to public-health experts and official sources:
Health-care workers and residents of long-term care facilities should be the initial groups to receive a COVID-19 vaccine while supply is limited, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommended last week. The independent panel’s non-binding recommendations are aimed at guiding state health officials’ vaccine-rollout decisions.
Essential workers, people with chronic health conditions that put them at greater risk for severe infection, and older adults are also likely to be suggested for vaccine prioritization going forward, reports suggest .
For the average American, “the earliest will likely be in the spring, but more likely over the summer,” Sandra Albrecht, a Columbia University assistant professor of epidemiology and chief epidemiologist for the science-communication project Dear Pandemic , told MarketWatch in an email.
Lt. Gen. Paul Ostrowski, the director of supply, production and distribution for Operation Warp Speed, the government’s vaccine development and distribution effort, said in a recent MSNBC interview that “100% of Americans that want the vaccine will have had the vaccine” by June.
“[Manufacturing] capacity is not static — it’s going to go up and up and up and up,” said Christopher Gill, an associate professor of global health at the Boston University School of Public Health.
“Each state has its own vaccine distribution playbook, so the manner in which vaccines will be distributed will differ state to state,” Albrecht said. “That said, there will likely be a variety of settings where the vaccine will be administered, and this includes hospitals, clinics, and pharmacies.”
The Pfizer vaccine must be stored at minus 94 degrees Fahrenheit — extreme cold that requires special freezers — while Moderna’s needs to be stored at minus 4 degrees Fahrenheit. “Because the two vaccines that are currently being considered in the U.S. have specific storage and handling requirements, it’s unlikely that the vaccine can just be administered in just any setting,” Albrecht said.
The Centers for Medicare and Medicaid Services have also suggested that states consider expanding the types of providers that can administer vaccines. In that vein, some dentists and optometrists are angling for permission to administer COVID-19 vaccines once they’re available, Kaiser Health News reported last week.
“A lot will probably depend on the setting for administration for the vaccine,” Albrecht said. For instance, because Pfizer’s vaccine needs to be stored at an ultra-cold temperature, “only hospitals and locations with such resources will be able to administer this vaccine,” she said.
“This means that large segments of the population will not have access to this vaccine, so there really won’t be an opportunity to choose unless there is a big shift in the supply of these freezers,” she said.
“Vaccine doses purchased with U.S. taxpayer dollars will be given to the American people at no cost,” the CDC says . “However, vaccination providers will be able to charge an administration fee for giving the shot to someone.”
Vaccine providers can get that fee reimbursed by public or private insurance companies for insured patients, and by the Health Resources and Services Administration’s Provider Relief Fund for uninsured patients, the agency said.
“My reading is the federal government is going to finance this one, and it’ll be just about the best investment in public health and economics that you’re ever going to find,” Sean Nicholson, a professor of policy and analysis management at Cornell University, told MarketWatch. “It seems like ensuring full uptake of the vaccine by paying for it is a no-brainer.”
Pfizer and Moderna have both said no serious safety issues emerged during their late-stage trials. Reported side effects from Pfizer’s vaccine trial include fatigue and headache, while Moderna’s trial included reports of fatigue, headache, joint pain, muscle pain, and pain and redness at the injection site, according to press releases from the companies. For more on side effects, check out MarketWatch’s deeper dive here .
With that said, “by definition, we know nothing of potential long-term side effects,” Gregory Poland, the director of the Mayo Clinic’s Vaccine Research Group, told MarketWatch. “We don’t know what we don’t know,” he said.
“We don’t have any data on safety or durability that extend out beyond less than a handful of months, and we don’t know anything about people who weren’t studied,” Poland added. Those groups include pregnant women , long-term care residents and highly immunocompromised people , he said. (Durability refers to how long a vaccine provides protection.)
We still know very little about any rare potential immunologic consequences of these vaccines, Gill added — answers that would only become known after millions of people had been vaccinated and followed over a number of years.
Both the Pfizer and Moderna vaccines will require two doses. The second dose of Pfizer’s vaccine is administered three weeks after the initial dose, while Moderna’s second shot comes four weeks after the first.
So how will your vaccine provider ensure that you return for that second jab? “This is going to be difficult. Vaccines that require two doses are notoriously difficult to administer because people often don’t return for the second dose,” Albrecht said. “There may be a need to incentivize people to ensure that they receive that second dose, and this may involve financial or other incentives.”
Donna Hallas, a clinical professor and program director for the pediatric nurse-practitioner program at the NYU Rory Meyers College of Nursing, said she thought vaccine distributors had an “obligation” to have patient follow-up plans in place. “In our current state of technology, it’s not anywhere near the problem we used to have,” she said. “You can send a reminder; you can send a text.”
On the government end, vaccine recipients will be given a card to help them track doses, the Defense Department said Wednesday. An image published by the department of a vaccination record card shows spaces for a person’s name, date of birth and patient number, as well as the product name, manufacturer and lot number; date; and provider or clinic site for each vaccine dose.
“We’ve set up everything [in a] draconian process, where when we sent out the ancillary kits, which have needles and syringes, we’ve included paper cards to be filled out and sent, given to the individuals reminding them of their next vaccine due date,” Gen. Gus Perna, Operation Warp Speed’s chief operating officer, said in a briefing . Individuals will be encouraged to take a picture of the card or keep it in their wallet, he added.
States are also working on plans for notifying individuals, Perna added, while pharmacies such as CVS /zigman2/quotes/209664499/composite CVS +0.38% and Walgreens /zigman2/quotes/203410933/composite WBA -1.11% “have established very elaborate tracking systems” to arrange appointments and notify people when they need their second shots.
“At the federal level … we have capability and capacity to send second-dose messages out only if and when it’s in collaboration with the state’s laws and regulations and policies,” he said, referring to the effort as a “triple-canopy approach.” “We’re doing our best to capture everybody to ensure that they get their second dose.”
The companies “will almost certainly say that you can’t mix the two vaccines,” Gill said, “and that is because there’s no data on what happens if you mix the two vaccines.” “Neither company wants to do that experiment to see if that would work — because then people would do that, and they don’t want people to do that,” he said.
While the manufacturers probably won’t study whether their vaccines are interchangeable, “academics like myself will,” Poland said — and there may be natural experiments from people who end up receiving mixed doses.
“Both doses are required to obtain the protective benefit of the vaccine — one is not enough,” Albrecht said. “The first injection primes the immune system to begin developing a response. But it’s the second injection that allows the immune system to develop the strong and long-lasting response needed to combat the virus for a longer period of time.”
Yes, you should, Poland said. Assuming that a valid, correctly performed test showed that you had COVID-19, “depending on severity, you may or may not have immunity, and we don’t know the durability of that immunity,” Poland said.
“We are not going to exclude people, at least in the long run, who have had COVID,” he said. “In the short term, that would be a potential possibility — in the very first early stage, where there’s inadequate vaccine.”
The CDC, for its part, notes there isn’t currently enough information to determine whether someone is protected from contracting COVID-19 again after being infected with the disease, or how long this natural immunity might last. “Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this,” it adds.
Until a COVID-19 vaccine is available and ACIP issues recommendations for vaccine use, “CDC cannot comment on whether people who had COVID-19 should get a COVID-19 vaccine,” the agency said.
“I think the jury is still out on this one, but we are hopeful. We are awaiting to see the actual data to determine how effective the vaccines are in the elderly,” Albrecht said. “It seems to work, but I know scientists are waiting to see the hard data on this.”
Pfizer reports that its vaccine is more than 94% effective in adults older than 65, while Moderna has not reported efficacy data by age group.
Keep in mind that ACIP’s recommendations “are just that — recommendations,” Albrecht added. “We still have to see whether states will adhere to these recommendations (they usually do), and whether the public (including residents in nursing homes) will consent to vaccination,” she said. “There are still several steps in the process before we get to a place where it’s safe to visit loved ones in nursing homes.”
In short, yes. We’ll need to wear masks and maintain physical distance from others even after vaccination until more data is available, Albrecht said. We still don’t know if the vaccines prevent people from becoming infected, she said — “we just know that people don’t actually get sick or have severe symptoms.”
“If people can still become infected but asymptomatic, they may still be able to transmit the virus to others. We don’t yet have an answer as to whether the vaccines actually prevent infection,” Albrecht said. What’s more, we don’t know how long protection from the vaccine will last, she said — and we’ll only know by tracking people over longer periods of time.
“For now, since we don’t know how long immunity will last, and because we still don’t know if the vaccines actually prevent infection altogether, many of the precautions will still need to be in place,” she said.
We also don’t know whether this will be a one-time vaccine with two doses, or an immunization we need annually like the flu vaccine, Hallas said.
“It’s going to take time,” Hallas said. “To think that we can just get a shot in the arm and take a mask off and go back to our normal behaviors is probably not going to happen.”